Archive
944 recalls were announced in November 2019.
Of the 944 recalls this month scored against our rubric, 5% are Critical, 43% are Severe.
Which agencies issued them
Zimmer Biomet is recalling specific spinal plates because non-highly polished implants may adhere to the packaging bag.
Zimmer Biomet is recalling 5,459,583 LPS-MOB Articular Surface Implants because non-highly polished implants may adhere to the LDPE bag.
Zimmer Biomet is recalling femorotibial and femoral nails because non-highly polished implants may adhere to the previous LDPE packaging bag.
Basic Reset Inc. is recalling 554 bottles of CBD Reset 750 oil because the product was marketed without an approved FDA application.
Zimmer Biomet is recalling specific periarticular plates because non-highly polished implants may adhere to the packaging bag.
Zimmer Biomet is recalling Metasul Femoral Heads because non-highly polished implants may adhere to the LDPE bag packaging.
Zimmer Biomet is recalling 5.4 million ankle implants because non-highly polished devices may adhere to the packaging bag.
Zimmer Biomet is recalling NCB-PH plates because non-highly polished implants may adhere to the LDPE bag packaging.
Basic Reset Inc. is recalling 339 bottles of Nuovi Firming Masque because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Productos La Samaritana, Inc. is recalling specific lots of La Samaritana Tortillas because they contain FD&C Red #40, which was not declared on the label.
Epic Enterprises is recalling Dr. Pepper 24-pack cans in Connecticut, Maine, and Rhode Island because they contain undeclared aspartame.
Lupin Pharmaceuticals is recalling Cephalexin for Oral Suspension bottles because a dead ant was identified as a foreign substance.
Helena Laboratories is recalling 899 SPIFE Alkaline Hemoglobin Kits because they contain incorrect instruction inserts referencing unavailable electrode parameters.
Productos La Samaritana is recalling specific lots of tomato tortillas because they contain FD&C Red #40, which is not declared on the label.
Lupin Pharmaceuticals is recalling specific lots of Cefdinir for Oral Suspension because a dead ant was found in the product.
Lupin Pharmaceuticals is recalling specific lots of Cefdinir for Oral Suspension because a dead ant was found in the product.
Sato Pharmaceutical Inc. is recalling Sankaijo Botanical Laxative tablets because the sennosides content is lower than the labeled claim.
Ford is recalling 2019-2020 F-150 vehicles because a battery cable fastener may loosen, potentially causing engine stalling, loss of braking or steering assist, or fire.
Ford is recalling 2016-2017 Lincoln MKX vehicles with 3.7L engines because the battery cable harness may contact a bracket, causing a short circuit and increasing fire risk.
Aston Martin is recalling 2018-2019 DB11, Vantage, and DBS Superleggera vehicles because passenger air bag fasteners may not be tightened properly, increasing injury risk in a crash.
Matrix Headgear is recalling Alpha motorcycle helmets because the retention system may fail, allowing the helmet to separate from the head during a crash.
Hooey is recalling about 6,600 children's sweatshirts with hood drawstrings due to a strangulation hazard. No injuries have been reported.
Ford is recalling 2018-2019 F-250, F-350, and F-450 Super Duty trucks because daytime running lights may not dim, increasing crash risk.
Ezzo Sausage Company is recalling approximately 25,115 pounds of ready-to-eat sausage products that may be contaminated with Listeria monocytogenes.
Mitsubishi is recalling 2012-2017 i-MiEV vehicles because water may corrode the brake vacuum pump, causing a loss of braking assist and increasing crash risk.
Nissan is recalling 391,479 vehicles because brake fluid may leak onto an electrical circuit board, creating a fire risk.
You Chang Trading, Inc. is recalling raw fish fillets labeled as Tilapia that were not presented for FSIS import re-inspection. The products were distributed in four states.
USDA FSIS issued a public health alert for specific ready-to-eat entrees containing ingredients recalled by Mann's Packing Co. due to possible Listeria monocytogenes contamination.
Daimler Trucks North America is recalling 2020 Freightliner Cascadia vehicles because brake chambers may contact the frame rail, potentially causing detachment and reduced braking.
Hyundai is recalling 2020 Palisade vehicles because mounting bolts may damage side curtain air bags, potentially preventing proper inflation in a crash.
Skylight is recalling Series I power adapters sold with digital photo frames because the casing can break, exposing metal prongs and posing an electrical shock hazard.
Thor Motor Coach is recalling specific Tuscany and Venetian motorhomes because rear reflectors may be positioned too high, reducing vehicle visibility and increasing crash risk.
General Motors is recalling 2014-2016 Chevrolet SS vehicles because corrosion in the steering connector may cause a loss of electric power steering assist, increasing the risk of a crash.
NHTSA is recalling 2019 Mercedes-Benz and Freightliner Sprinter vans because a fuel system defect may cause diesel leaks or fuel overflow.
Rastelli Bros. is recalling approximately 130,464 pounds of raw ground beef products that may contain plastic. The recall affects products shipped to five states.
Ethicon Endo-Surgery Inc is recalling 2,112 Echelon Flex Powered Plus ENDOPATH 60mm Staplers worldwide due to out-of-specification anvil components that may compromise staple line integrity.
Vita Food Products is recalling Nathan's Cold Smoked Wild Salmon because testing confirmed the presence of Listeria monocytogenes.
Fitoterapia USA Inc. is recalling Mero Macho Passion Fruit Vitamin C Liquid Supplement because it was marketed without an approved NDA/ANDA and found to be tainted with Tadalafil.
AVKARE Inc. is recalling Ranitidine Hydrochloride Capsules 300 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA). The affected bottles were distributed in Colorado and Missouri.
Peekay International Inc. is recalling specific brands of dry apricots because they contain undeclared sulfites. The product was distributed in six states.
Daimler Vans USA is recalling 2019 Mercedes-Benz and Freightliner Sprinter vans because a front seat weld may break in a crash, increasing injury risk.
Innoveix Pharmaceuticals is recalling 1,747 vials of compounded Sermorelin injection because the product lacks sterility assurance.
Thoratec is recalling CentriMag Acute Circulatory Support System motors due to reports of motor and pump issues caused by electromagnetic interference.
AvKare is recalling Ranitidine Hydrochloride Capsules 150 mg because N-nitrosodimethylamine (NDMA) was found in the active ingredient.
Innoveix Pharmaceuticals is recalling 290 vials of Lyophilized Human Chorionic Gonadotropin 5,500 USP Units due to a lack of sterility assurance.
Simmons Prepared Foods is recalling approximately 2.07 million pounds of poultry products that may contain metal. The products were shipped to institutions in eight states.
Ethicon Endo-Surgery Inc is recalling 255 units of the ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler because an out-of-specification anvil may cause malformed staples and compromised staple lines.
Ethicon is recalling 5,040 Echelon Flex Powered Plus Endopath 60mm Staplers due to out-of-specification anvil components that may compromise staple line integrity.
Innoveix Pharmaceuticals is recalling 413 vials of Lyophilized Human Chorionic Gonadotropin 5,000 USP Units due to a lack of sterility assurance.
Ethicon is recalling Echelon Flex Endopath 60mm Staplers due to out-of-specification anvil components that may compromise staple line integrity.
Rong Shing Trading NY Inc is recalling Glam Day Nougat Candy because it may contain undeclared milk and egg allergens. The product was distributed to retailers in 17 states.
Medical Components, Inc dba MedComp is recalling the C3 Wave App v. 2.0.5 because it malfunctions on iOS 12, preventing ECG display during PICC procedures.
Innoveix Pharmaceuticals is recalling 3,905 vials of Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection due to a lack of sterility assurance.
Blue Bird is recalling 2013-2020 Vision school buses with Ford engines because brake lights may stay on continuously, increasing crash risk.
Stryker Neurovascular is recalling 831 units of Synchro2 Soft Guidewires due to a potential loss of sterility. The recall covers units distributed worldwide.
Han Yang Corp. is recalling Honey Donuts (Yahk Gwa) due to undeclared wheat. The product was distributed in Washington state.
Valeritas is recalling 60 DEMO No Needle Corrugated Cartons because they may contain a needle. The units were distributed nationwide in the U.S.
Valeritas is recalling DEMO No Needle Corrugated Cartons because there is a potential for the units to contain a needle.
Valeritas is recalling 21,714 DEMO No Needle Corrugated Cartons because they may contain a needle. The recall covers units distributed nationwide in the U.S.
Centurion Medical Products Corporation is recalling 11,260 Port Access Kits distributed in Illinois. The recall was initiated by the supplier due to an issue with GRIPPER Needles.
Grand Strand Sandwich Company is recalling chicken salad on croissant sandwiches due to possible Listeria monocytogenes contamination.
ConvaTec is recalling convex two-piece ostomy skin barriers manufactured between February 2017 and September 2018 because the stoma hole may be off-center.
Rong Shing Trading Inc. is recalling Ganchi Naiweitangpian Candy because it contains undeclared milk. The product was distributed to retailers in seven states.
Pajunk GmbH is recalling Sprotte Lumbar Puncture Needles because a packaging sealing issue may affect sterility. The recall covers 40,475 devices distributed worldwide.
Skacel Collection is recalling US 6 (4.0mm) addi® FlipStix knitting needles because the aluminum shafts can split or burst, posing a laceration hazard.
Super World Trading Inc. is recalling 12-ounce bags of dried dates due to undeclared sulfites. The product was distributed in Florida, Georgia, Texas, and Maryland.
Grand Strand Sandwich Company is recalling chicken salad sandwiches due to possible Listeria monocytogenes contamination. The product was distributed in North and South Carolina.
Blue Bird is recalling 2013-2020 Vision transit buses with Ford engines because a defective brake light switch bracket may cause brake lights to stay on, increasing crash risk.
TIDI Products is recalling Posey Connected Twice-As-Tough Cuffs because they do not meet design specifications. The recall affects 7,692 units distributed in the US and internationally.
LivaNova USA Inc. is recalling SORIN Heater-Cooler System 3T units because a chemical reaction may render the water preservative ineffective, potentially allowing micro-organism growth.
Draeger Medical Systems is recalling 5,634 Infinity Acute Care System monitors due to cybersecurity vulnerabilities that may cause device reboots and loss of alarm functionality.
GE Healthcare is recalling 43 CardioLab/ComboLab Recording Systems because a failure in connected devices could cause electrical shock to patients.
Valeritas is recalling 852 DEMO No Needle Corrugated Cartons because they may contain a needle. The units were distributed nationwide in the U.S.
New Seasons Market LLC is recalling Honey Cake because the packaging lists buttermilk and sour cream but fails to declare milk as an allergen.
Intuitive Surgical is recalling EndoWrist Suction Irrigator instruments because silicone particles may form and be introduced into patients during irrigation.
Baxter Healthcare is recalling 504 TherMax Blood Warmer Units because they may not meet electrical safety standards for protective earth connections.
Becton Dickinson is recalling specific lots of BD Vacutainer Eclipse Blood Collection Needles because a missing bevel on the non-patient end caused blood leakage.
Valeritas is recalling DEMO No Needle Corrugated Cartons because they may contain a needle. The recall covers 49,074 units distributed nationwide.
Senseonics is recalling 1,344 Eversense CGM sensors nationwide because they may stop working early due to inadequate hydration of the glucose-sensing surface.
Apotex Inc. is recalling specific bottles of Atorvastatin Calcium 40 mg tablets because a single Pravastatin 40 mg tablet was found inside one bottle.
Blue Bell Creameries is recalling specific lots of Butter Crunch Ice Cream due to possible foreign material in the product.
Synthes (USA) Products LLC is recalling six 3.5mm spinal screws that measure 4.0mm in diameter. The product was distributed to New Jersey.
Taro Pharmaceuticals is recalling 5,280 bottles of Children's Ibuprofen Oral Suspension due to the presence of small inert plastic particles.
Taro Pharmaceuticals is recalling 5,190 bottles of Children's Ibuprofen Oral Suspension because small particles of inert plastic may be present.
Medtronic is recalling 6,713 CareLink Encore Programmer units worldwide because they may display inaccurate remaining longevity estimates for certain implanted cardiac devices. The issue does not impact device functionality.
Mindray is recalling 107 Accutorr 7 Vital Signs Monitors because the NIBP valve assembly board contains software features not included in the current marketing clearance.
Hycor Biomedical is recalling HYTEC Stop Solution bottles that may leak a caustic sodium hydroxide solution. The product is used in specific allergy testing kits.
Mylan Pharmaceuticals is recalling 4,272 bottles of Prasugrel 5 mg tablets because they failed to meet dissolution specifications.
Mindray is recalling 9 Rosebud Vital Signs Monitors because the NIBP valve assembly board contains software features not included in the current marketing clearance.
Glenmark Pharmaceuticals is recalling Estradiol Vaginal Inserts because the applicator plunger may be difficult to push.
Taro Pharmaceuticals is recalling 639,325 bottles of Ibuprofen Oral Suspension USP because they may contain small particles of inert plastic material introduced during manufacturing.
Stryker Neurovascular is recalling 305 Synchro2 guidewires because the product labels contain a typographical error in the millimeter dimension.
The Great Spirits Baking Company is recalling Jack Daniels Tennessee Whiskey Cakes because they may contain mold before the expiration date.
OrthoPediatrics Corp is recalling 969 Adolescent Nail Attachment Bolts because binding between the bolt and nail may delay surgical procedures.
Medtronic is recalling CareLink SmartSync Device Manager units because they may display inaccurate remaining longevity estimates for certain implanted cardiac devices. The issue does not impact device functionality.
Alto Development Corp is recalling 209 Thorecon Plating System Kits because a molding defect renders the disposable tensioners inoperable.
Mindray is recalling 14 Rosie4 Vital Signs Monitors because the NIBP valve assembly board contains software features not included in the current marketing clearance.
Anewmed Corporation is recalling 1,749 medical devices because the contract sterilizer lacked adequate packaging data to support the 2-year shelf life.
Keystone RV Company is recalling 2014 Springdale 253FWRLLS trailers because the Federal Identification Tag may list incorrect tire, rim, and axle sizes, potentially leading to unintentional overloading.
Centurion Medical Products Corporation is recalling 200 Port Access Infusion Kits with 1-inch needles distributed in Illinois due to a supplier-initiated recall.
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